AccessGUDID - DEVICE: TRUFILL (10886704085324)

GUDID

Device Identifier (DI) Information

Brand Name: TRUFILL
Version or Model: 632400NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 632400NA
Company Name: Cerenovus, Inc.

Primary DI Number: 10886704085324
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 607846297 *Terms of Use

Device Description: TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: (2) 1 g n-BCA, self-piercing caps, 1 g Ta Powder, 10 mL Ethiodized Oil, (3) 1 mL and (3) 3 mL syringes, 30 mL beaker, 18 G blunt fill needle, (2) 21 G hypodermic needles, syringe labels

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60939	Neurovascular embolization plug	A non-bioabsorbable material (e.g., gel, liquid) intended to be implanted in a neurovascular blood vessel, to obstruct blood flow to treat a brain arteriovenous malformation (bAVM). It may be supplied as a liquid [e.g., ethylene vinyl alcohol (EVOH)], gel or powder intended to solidify or expand in situ to create a barrier to blood flow (embolus); it contains no pharmaceutical agents. It may be supplied with dedicated instruments for implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KGG	tissue adhesive for use in embolization of brain arteriovenous malformations

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990040	031

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d4f0b9d2-dcb1-4a18-be0e-afbb870ae0f2
Public Version Date: October 31, 2023
Public Version Number: 1
DI Record Publish Date: October 23, 2023